M.Pharm (Pharmacy Practice)

Table – VII: Course of study for (Pharmacy Practice)

Course Code

Course Credit Hours

Credit Points

Hrs/wk Marks

Semester I MPP101T Clinical Pharmacy Practice 4 4 4 100 MPP102T Pharmacotherapeutics -I 4 4 4 100 MPP103T! Hospital & Community Pharmacy 4 4 4 100 MPP104T! Clinical Research 4 4 4 100 MPP101P! Pharmacy Practice Practical - I 6 6 12 100 Seminar/Assignment 11 6

Total 22 22 28 500 Semester II

MPP201T Principles of Quality Use of Medicines

4 4 4 100

MPP202T! Pharmacotherapeutics II 4 4 4 100 MPP203T Clinical Pharmacokinetics &

Therapeutic Drug Monitoring 4 4 4 100

MPP204T Pharmacoepidemiology & Pharmacoeconomics

4 4 4 100

MPP201P Pharmacy Practice Practical - II 6 6 12 100 Seminar/Assignment 11 6 Total 22 22 28 500 !

Clinical Pharmacy Practice (MPP101T)

Scope This course is designed to impart the basic knowledge and skills that are required to practice pharmacy including the provision of pharmaceutical care services to both healthcare professionals and patients in clinical settings. Objectives Upon completion of this course it is expected that students shall be able to:

•! Understand the elements of pharmaceutical care and provide comprehensive patient care services

•! Interpret the laboratory results to aid the clinical diagnosis of various disorders •! Provide integrated, critically analyzed medicine and poison information to enable

healthcare professionals in the efficient patient management THEORY 60 Hrs

UNIT I 12 Hrs

Introduction to Clinical Pharmacy: Definition, evolution and scope of clinical pharmacy, International and national scenario of clinical pharmacy practice, Pharmaceutical care Clinical Pharmacy Services: Ward round participation, Drug therapy review (Drug therapy monitoring including medication order review, chart endorsement, clinical review and pharmacist interventions) UNIT II 12 Hrs

Clinical Pharmacy Services: Patient medication history interview, Basic concept of medicine and poison information services, Basic concept of pharmacovigilance, Hemovigilance, Materiovigilance and AEFI, Patient medication counselling, Drug utilisation evaluation, Documentation of clinical pharmacy services, Quality assurance of clinical pharmacy services UNIT III 12 Hrs Patient Data & Practice Skills: Patient's case history - its structure and significances in drug therapy management, Common medical abbreviations and terminologies used in clinical practice, Communication skills: verbal and non-verbal communications, its applications in patient care services. Lab Data Interpretation: Haematological tests, Renal function tests, Liver function tests

UNIT IV 12 Hrs Lab Data Interpretation: Tests associated with cardiac disorders, Pulmonary function tests, Thyroid function tests, Fluid and electrolyte balance, Microbiological culture sensitivity tests UNIT V 12 Hrs Medicine Information Service: Definition and need for medicine information service, Medicine information resources, Systematic approach in answering medicine information queries, Preparation of verbal and written response, Establishing a drug information centre Poison Information Service: Definition, need, organization and functions of poison information centre

REFERENCES

1.! Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills. Orient Blackswan Pvt. Ltd.

2.! The Society of Hospital Pharmacists of Australia. Practice Standards and Definitions.

3.! Scott LT. Basic skills in interpreting laboratory data - American Society of Health System Pharmacists Inc.

4.! Relevant review articles from recent medical and pharmaceutical literature.

Pharmacotherapeutics -I (MPP102T)!

Scope This course aims to enable the students to understand the different treatment approaches in managing various disease conditions. Also, it imparts knowledge and skills in optimizing drug therapy of a patient by individualising the treatment plan through evidence-based medicines. Objectives Upon completion of this course it is expected that students shall be able to: •! Describe and explain the rationale for drug therapy •! Summarize the therapeutic approach for management of various disease conditions

including reference to the latest available evidence •! Discuss the clinical controversies in drug therapy and evidence based medicine •! Prepare individualized therapeutic plans based on diagnosis •! Identify the patient specific parameters relevant in initiating drug therapy, and

monitoring therapy (including alternatives, time- course of clinical and laboratory indices of therapeutic response and adverse effect/s)

THEORY 60 Hrs

Etiopathogenesis and pharmacotherapy of diseases associated with following systems

UNIT I 12 Hrs

Cardiovascular system:

Hypertension, Congestive cardiac failure, Acute coronary syndrome, Arrhythmias, Hyperlipidemias, Rheumatic heart disease

UNIT II 12 Hrs

Respiratory system:

Asthma, Chronic obstructive airways disease, Drug induced pulmonary diseases

Endocrine system:

Diabetes, Thyroid diseases

UNIT III 12 Hrs

Gastrointestinal system:

Peptic ulcer diseases, Reflux esophagitis, Inflammatory bowel diseases, Jaundice & hepatitis

UNIT IV 12 Hrs

Gastrointestinal system:

Cirrhosis, Diarrhea and Constipation, Drug-induced liver disease

Hematological diseases:

Anemia, Deep vein thrombosis, Drug induced hematological disorders

UNIT V 12 Hrs

Bone and joint disorders:

Rheumatoid arthritis, Osteoarthritis, Gout, Osteoporosis

Dermatological Diseases:

Psoriasis, Eczema and scabies, impetigo, drug induced skin disorders

Ophthalmology:

Conjunctivitis, Glaucoma

REFERENCES

1.! Roger and Walker. Clinical Pharmacy and Therapeutics - Churchill Livingstone Publication

2.! Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach- Appleton & Lange Publication

3.! Robins SL. Pathologic basis of disease -W.B. Saunders Publication 4.! Eric T. Herfindal. Clinical Pharmacy and Therapeutics- Williams and Wilkins

Publication 5.! Lloyd Young and Koda-Kimble MA Applied Therapeutics: The clinical Use of

Drugs- Lippincott Williams and Wilkins Publication 6.! Chisholm- Burns Wells Schwinghammer Malone and Joseph P Dipiro.

Pharmacotherapy Principles and practice-– McGraw Hill Publication 7.! Carol Mattson Porth. Principles of Pathophysiology- Lippincott Williams and Wilkins

Publication 8.! Harrison's. Principles of Internal Medicine - McGraw Hill Publication 9.! Relevant review articles from recent medical and pharmaceutical literature

Hospital & Community Pharmacy (MPP103T) Scope This course is designed to impart basic knowledge and skills that are required to practice pharmacy in both hospital and community settings.

Objectives Upon completion of this course it is expected that students shall be able to:

•! Understand the organizational structure of hospital pharmacy •! Understand drug policy and drug committees •! Know about procurement & drug distribution practices •! Know the admixtures of radiopharmaceuticals •! Understand the community pharmacy management •! Know about value added services in community pharmacies

THEORY 60 Hrs

UNIT I 12 Hrs

Introduction to Hospitals: Definition, classification, organizational structure Hospital Pharmacy: Definition, Relationship of hospital pharmacy department with other departments, Organizational structure, legal requirements, work load statistics, Infrastructural requirements, Hospital Pharmacy Budget and Hospital Pharmacy management Hospital Drug Policy: Pharmacy & Therapeutics Committee, Infection Control committee, Research & Ethics Committee UNIT II 12 Hrs Hospital Drug Policy: Hospital Formulary Guidelines and its development, Developing Therapeutic guidelines, Drug House Management: Drug procurement process, and methods of Inventory control, Methods of Drug distribution, Intravenous admixtures, Hospital Waste Management UNIT III 12 Hrs Education and training: Training of technical staff, Training and continuing education for pharmacists, Pharmacy students, Medical staff and students, Nursing staff and students, Formal and informal

meetings and lectures, Drug and therapeutics newsletter. Community Pharmacy Practice: Definition, roles & responsibilities of community pharmacists, relationship of community pharmacists with other health care providers Community Pharmacy management: Legal requirements to start community pharmacy, site selection, lay out & design, drug display, super drug store model, accounts UNIT IV 12 Hrs

Prescription: Legal requirements & interpretation, prescription related problems Responding to symptoms of minor ailments: Head ache, pyrexia, menstrual pains, food and drug allergy, OTC medication: Rational use of over the counter medications Medication adherence and Patient referrals to the doctors ADR monitoring in community pharmacies UNIT V 12 Hrs Health Promotion: Definition and health promotion activities, family planning, Health screening services, first aid, prevention of communicable and non-communicable diseases, smoking cessation, Child & mother care Home Medicines Review Program: Definition, objectives, Guidelines, method and outcomes, Research in community pharmacy REFERENCES

1.! Hassan WE. Hospital Pharmacy. Lec and Febiger Publication. 2.! Allwood MC and J T Fell. Textbook of hospital pharmacy. Blackwell Science Ltd. 3.! Trevor M Speight and Nicholas H G Holford. Avery’s Drug Treatment. Wiley India

Pvt. Ltd. 4.! Remington’s Pharmaceutical Science. John Wiley & Sons 5.! Relevant review articles from recent medical and pharmaceutical literature

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Clinical Research (MPP104T)

Scope This course aims to provide the students an opportunity to learn drug development process especially the phases of clinical trials and also the ethical issues involved in the conduct of clincal research. Also, it aims to imparts knowledge and develop skills on conceptualizing, designing, conducting and managing clinical trials.

Objectives Upon completion of this course it is expected that students shall be able to:

•! Know the new drug development process. •! Understand the regulatory and ethical requirements. •! Appreciate and conduct the clinical trials activities •! Know safety monitoring and reporting in clinical trials •! Manage the trial coordination process

THEORY 60 Hrs

UNIT I 12 Hrs

Drug development process: Introduction, various approaches to drug discovery, Investigational new drug application submission Ethics in Biomedical Research: Ethical Issues in Biomedical Research – Principles of ethics in biomedical research, Ethical committee [institutional review board] - its constitution and functions, Challenges in implementation of ethical guidelines UNIT II 12 Hrs Types and Designs used in Clinical Research: Planning and execution of clinical trials, Various Phases of clinical trials, Bioavailability and Bioequivalence studies, Randomization techniques (Simple randomization, restricted randomization, blocking method and stratification), Types of research designs based on Controlling Method (Experimental, Quasi experimental, and Observational methods) Time Sequences (Prospective and Retrospective), Sampling methods (Cohort study, case Control study and cross sectional study), Health outcome measures (Clinical & Physiological, Humanistic and economic) Clinical Trial Study team: Roles and responsibilities of: Investigator, Study Coordinator, Sponsor, Monitor, Contract Research Organization. !

UNIT III 12 Hrs

Clinical trial Documents: Guidelines to the preparation of following documents: Protocols, Investigator’s Brochure, Informed Consent Form, Case report forms, Contracts and agreements, Dairy Cards Clinical Trial Start up activities:

Site Feasibility Studies, Site/Investigator selection, Pre-study visit, Investigator meeting, Clinical trial agreement execution, Ethics committee document preparation and submission

UNIT IV 12 Hrs

Investigational Product: Procurement and Storage of investigation product Filing procedures:

Essential documents for clinical trial, Trial Master File preparation and maintenance, Investigator Site File, Pharmacy File, Site initiation visit, Conduct, Report and Follow up

Clinical Trial Monitoring and Close out:

Preparation and conduct of monitoring visit:

Review of source documents, CRF, ICF, IP storage, accountability and reconciliation, Study Procedure, EC communications, Safety reporting, Monitoring visit reporting and follow-up

Close-Out visit:

Study related documents collection, Archival requirement, Investigational Product reconciliation and destruction, Close-Out visit report

UNIT V 12 Hrs

Quality Assurance and Quality Control in Clinical Trials:

Types of audits, Audit criteria, Audit process, Responsibilities of stakeholders in audit process, Audit follow-up and documentation, Audit resolution and Preparing for FDA inspections, Fraud and misconduct management

Data Management:

Infrastructure and System Requirement for Data Management:

Electronic data capture systems, Selection and implementation of new systems, System validation and test procedures, Coding dictionaries, Data migration and archival

Clinical Trial Data Management:

Standard Operating Procedures, Data management plan, CRF & Data base design considerations, Study set-up, Data entry, CRF tracking and corrections, Data cleaning, Managing laboratory and ADR data, Data transfer and database lock, Quality Control and Quality Assurance in CDM, Data mining and warehousing

REFERENCES

1.! Lionel. D. Edwards, Andrew. J. Fletcher Anthony W Fox, Peter D Stonier. Principles and practice of pharmaceutical medicine. Wiley Blackwell.

2.! Julia Lloyd and Ann Raven Ed. Handbook of clinical research. Churchill Livingstone. 3.! Giovanna di Ignazio, Gareth Hayes. Principles of Clinical Research. Routledge. 4.! Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for

Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.

5.! International Council for Harmonization of Technical requirements for Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice

6.! Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.

7.! David Machin, Simon Day and Sylvan Green. Textbook of Clinical Trials. John Wiley & Sons.

8.! Richard K Rondel, Sheila A Varley, Colin F Webb. Clinical Data Management. Wiley India Pvt. Ltd.

9.! Laurence Brunton, Bruce A Chabner and Bjorn Knollman. Goodman & Gilman’s The Pharmacological basis of therapeutics. McGraw Hill Education.

10.!Relevant review articles from recent medical and pharmaceutical literature.

Pharmacy Practice Practical - I (MPP101P)

Pharmacy Practice practical component includes experiments covering important topics of the courses Clinical Pharmacy Practice, Pharmacotherapeutics-I, Hospital & Community Pharmacy and Clinical Research. List of Experiments (20)

1.! Treatment Chart Review (one) 2.! Medication History Interview (one) 3.! Patient Medication Counseling (two) 4.! Drug Information Query (two) 5.! Poison Information Query (one) 6.! Lab Data Interpretation (two) 7.! Presentation of clinical cases of various disease conditions adopting Pharmaceutical

Care Plan Model (five) 8.! ABC Analysis of a given list of medications (one) 9.! Preparation of content of a medicine, with proper justification, for the inclusion in the

hospital formulary (one) 10.!Formulation and dispensing of a given IV admixtures (one) 11.!Preparation of a patient information leaflet (one) 12.!Preparation of Study Protocol (one) 13.!Preparation of Informed Consent Form (one)

Principles of Quality Use of Medicines (MPP201T)

Scope: This course is designed to impart basic knowledge and skills that are required to

practice quality use of medicines (QUM) in different healthcare settings and also to promote

quality use of medicines, in clinical practice, through evidence-based medicine approach.

Objectives:

Upon completion of this course it is expected that students shall be able to:

•! Understand the principles of quality use of medicines

•! Know the benefits and risks associated with use of medicines

•! Understand regulatory aspects of quality use of medicines

•! Identify and resolve medication related problems

•! Promote quality use of medicines

•! Practice evidence-based medicines

THEORY 60 Hrs

UNIT I 12 Hrs

Introduction to Quality use of medicines (QUM):

Definition and Principles of QUM, Key partners and responsibilities of the partners, Building

blocks in QMC, Evaluation process in QMC, Communication in QUM, Cost effective

prescribing

UNIT II 12 Hrs

Concepts in QUM:

Evidence based medicine: Definition, concept of evidence based medicine, Approach and practice of evidence based medicine in clinical settings Essential drugs: Definition, need, concept of essential drug, National essential drug policy and list Rational drug use: Definition, concept and need for rational drug use, Rational drug prescribing, Role of pharmacist in rational drug use

UNIT III 12 Hrs

QUM in various settings:

Hospital settings, Ambulatory care/Residential care, Role of health care professionals in

promoting the QUM, Strategies to promote the QUM, Impact of QUM on E-health,

integrative medicine and multidisciplinary care.

QUM in special population:

Pediatric prescribing, Geriatric prescribing, Prescribing in pregnancy and lactation,

Prescribing in immune compromised and organ failure patients

UNIT IV 12 Hrs

Regulatory aspects of QUM in India:

Regulation including scheduling, Regulation of complementary medicines, Regulation of

OTC medicines, Professional responsibility of pharmacist, Role of industry in QUM in

medicine development

UNIT V 12 Hrs

Medication errors:

Definition, categorization and causes of medication errors, Detection and prevention of

medication errors, Role of pharmacist in monitoring and management of medication

errors

Pharmacovigilance:

Definition, aims and need for pharmacovigilance, Types, predisposing factors and

mechanism of adverse drug reactions (ADRs), Detection, reporting and monitoring of ADRs,

Causality assessment of ADRs, Management of ADRs, Role of pharmacist in

pharmacovigilance

REFERENCES:

1.! Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills. Orient Blackswan Pvt. Ltd. – (latest edition)

2.! Elizabeth B Andrews, Nicholas Moore. Mann’s Pharmacovigilance. Wiley Blackwell (Latest Edition)

3.! Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach- Appleton & Lange Publication (Latest Edition)

4.! Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based Medicine: How to practice and teach it. Elsevier Health Sciences. (Latest Edition)

5.! Cohen MR. Medication Errors. American Pharmaceutical Association. (Latest Edition)

6.! Online:

•! http://medicinesaustralia.com.au/files/2012/05/MA_QUM_External_Reduced.pdf

•! http://curriculum.racgp.org.au/statements/quality-use-of-medicines/

•! http://www.rug.nl/research/portal/files/14051541/Chapter_2.pdf

7. Relevant review articles from recent medical and pharmaceutical literature.

Pharmacotherapeutics -II (MPP202T) Scope This course aims to enable the students to understand the different treatment approaches in managing various disease conditions. Also, it imparts knowledge and skills in optimizing drug therapy of a patient by individualising the treatment plan through evidence-based medicines. Objectives Upon completion of this course it is expected that students shall be able to: •! Describe and explain the rationale for drug therapy •! Summarize the therapeutic approach for management of various disease conditions

including reference to the latest available evidence •! Discuss the clinical controversies in drug therapy and evidence based medicine •! Prepare individualized therapeutic plans based on diagnosis •! Identify the patient specific parameters relevant in initiating drug therapy, and

monitoring therapy (including alternatives, time- course of clinical and laboratory indices of therapeutic response and adverse effect/s)

THEORY 60 Hrs

UNIT I 12 Hrs

Nervous system:

Epilepsy, Parkinson's disease, Stroke, Headache, Alzheimer’s disease, Neuralgias and Pain pathways and Pain management

UNIT II 12 Hrs

Psychiatric disorders:

Schizophrenia, Depression, Anxiety disorders, Sleep disorders, Drug induced psychiatric disorders

Renal system:

Acute renal failure, Chronic renal failure, Renal dialysis, Drug induced renal disease

UNIT III 12 Hrs

Infectious diseases:

General guidelines for the rational use of antibiotics and surgical prophylaxis, Urinary tract infections, Respiratory tract infections, Gastroenteritis, Tuberculosis, Malaria, Bacterial endocarditis, Septicemia

UNIT IV 12 Hrs

Infectious diseases:

Meningitis, HIV and opportunistic infections, Dengue fever, H1N1, Helmenthiasis, Fungal infections

Gynaecological disorders: Dysmenorrhea, Hormone replacement therapy

UNIT V 12 Hrs Oncology:

General principles of cancer chemotherapy, pharmacotherapy of breast cancer, lung cancer, head & neck cancer, hematological malignancies, Management of nausea and vomiting, Palliative care

REFERENCES

1.! Roger and Walker. Clinical Pharmacy and Therapeutics - Churchill Livingstone Publication

2.! Joseph T. Dipiro et al. Pharmacotherapy: A Pathophysiologic Approach- Appleton & Lange Publication

3.! Robins SL. Pathologic basis of disease -W.B. Saunders Publication 4.! Eric T. Herfindal. Clinical Pharmacy and Therapeutics- Williams and Wilkins

Publication 5.! Lloyd Young and Koda-Kimble MA Applied Therapeutics: The clinical Use of

Drugs- Lippincott Williams and Wilkins Publication 6.! Chisholm- Burns Wells Schwinghammer Malone and Joseph P Dipiro.

Pharmacotherapy Principles and practice-– McGraw Hill Publication 7.! Carol Mattson Porth. Principles of Pathophysiology- Lippincott Williams and Wilkins

Publication 8.! Harrison's. Principles of Internal Medicine - McGraw Hill Publication 9.! Relevant review articles from recent medical and pharmaceutical literature

Clinical Pharmacokinetics and Therapeutic Drug Monitoring (MPP203T)

Scope

This course is designed to enable students to understand the basics principles and applications of pharmacokinetics in designing the individualized dosage regimen, to interpret the plasma drug concentration profile in altered pharmacokinetics, drug interactions and in therapeutic drug monitoring processes to optimize the drug dosage regimen. Also, it enable students to understand the basic concepts of pharmacogenetics, pharmacometrics for modeling and simulation of pharmacokinetic data.

Objectives Upon completion of this course it is expected that students shall be able to:

•! Design the drug dosage regimen for individual patients •! Interpret and correlate the plasma drug concentrations with patients' therapeutic

outcomes •! Recommend dosage adjustment for patients with renal/ hepatic impairment •! Recommend dosage adjustment for paediatrics and geriatrics •! Manage pharmacokinetic drug interactions •! Apply pharmacokinetic parameters in clinical settings •! Interpret the impact of genetic polymorphisms of individuals on pharmacokinetics and

or pharmacodynamics of drugs •! Do pharmacokinetic modeling for the given data using the principles of

pharmacometrics

THEORY 60 Hrs

UNIT I 12 Hrs

Introduction to Clinical pharmacokinetics: Compartmental and Non compartmental models, Renal and non-renal clearance, Organ

extraction and models of hepatic clearance, Estimation and determinants of bioavailability, Multiple dosing, Calculation of loading and maintenance doses

Designing of dosage regimens: Determination of dose and dosing intervals, Conversion from intravenous to oral dosing,

Nomograms and Tabulations in designing dosage regimen UNIT II 12 Hrs Pharmacokinetics of Drug Interaction: Pharmacokinetic drug interactions, Inhibition and Induction of Drug metabolism, Inhibition

of Biliary Excretion

Pharmacogenetics: Genetic polymorphism in Drug metabolism: Cytochrome P-450 Isoenzymes, Genetic Polymorphism in Drug Transport and Drug Targets, Pharmacogenetics and Pharmacokinetic / Pharmacodynamic considerations Introduction to Pharmacometrics: Introduction to Bayesian Theory, Adaptive method or Dosing with feedback, Analysis of Population pharmacokinetic Data

UNIT III 12 Hrs

Non Linier Mixed Effects Modelling: The Structural or Base Model, Modeling Random Effects, Modeling Covariate Relationships,

Mixture Model, Estimation Methods, Model Building Techniques, Covariate Screening Methods, Testing the model assumptions, Precision of the parameter estimates and confidence intervals, Model misspecification and violation of the model assumptions, Model Validation, Simulation of dosing regimens and dosing recommendations, Pharmacometrics software

UNIT IV 12 Hrs Altered Pharmacokinetics: Drug dosing in the elderly, Drug dosing in the paediatrics, Drug dosing in the obese patients,

Drug dosing in the pregnancy and lactation, Drug dosing in the renal failure and extracorporeal removal of drugs, Drug dosing in the in hepatic failure

UNIT V 12 Hrs Therapeutic Drug monitoring: Introduction, Individualization of drug dosage regimen (Variability – Genetic, age, weight,

disease and Interacting drugs), Indications for TDM, Protocol for TDM, Pharmacokinetic/Pharmacodynamic Correlation in drug therapy, TDM of drugs used in the following conditions: Cardiovascular disease: Digoxin, Lidocaine, Amiodarone; Seizure disorders: Phenytoin, Carbamazepine, Sodium Valproate; Psychiatric conditions: Lithium, Fluoxetine, Amitriptyline; Organ transplantations: Cyclosporine; Cytotoxic Agents: Methotrexate, 5-FU, Cisplatin; Antibiotics: Vancomycin, Gentamicin, Meropenem

REFERENCES

1.! Leon Shargel and Andrew B C Yu. Applied Biopharmaceutics & Pharmacokinetics. McGraw Hill Education

2.! Peter L. Bonate. Pharmacokinetic - Pharmacodynamic Modelling and Simulation. Springer.

3.! Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E. Evans. Applied

Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic Drug Monitoring. Lippincott Williams & Wilkins

4.! Steven How-Yan Wong, Irving Sunshine. Handbook of Analytical Therapeutic Drug Monitoring and Toxicology. CRC Press.

5.! Soraya Dhillon, Andrzej Kostrzewski. Clinical Pharmacokinetics. Pharmaceutical Press.

6.! Joseph T. Dipiro, William J. Spruill, Robert A. Blouin, Jane M. Pruemer and William E. Wade. Concepts in Clinical Pharmacokinetics. American Society of Health-System Pharmacists.

7.! Malcolm Rowland, Thomas N. Tozer. Clinical Pharmacokinetics and pharmacodynamics: concepts and applications. Lippincott Williams & Wilkins.

8.! William Evans, Jerome J Schentag, William J Jusko. Applied Pharmacokinetics: Principles Therapeutic Drug Monitoring. Lippincott Williams & Wilkins

9.! Michael E. Winter. Basic Clinical Pharmacokinetics. Lippincott Williams & Wilkins.

10.!Milo Gibaldi. Biopharmaceutics and Clinical Pharmacokinetics. Pharma Book

Syndicate.

11.!John E. Murphy. Clinical Pharmacokinetics. American Society of Health- System Pharmacists.

12.!Relevant review articles from recent medical and pharmaceutical literature

Pharmacoepidemiology & Pharmacoeconomics (MPP204T)

Scope

This course enable students to understand various pharmacoepidemiological methods and their clinical applications. Also, it aims to impart knowledge on basic concepts, assumptions, terminology, and methods associated with pharmacoeconomics and health related outcomes, and when should be appropriate pharmacoeconomic model should be applied for a health care regimen.

Objectives Upon completion of this course it is expected that students shall be able to: •! Understand the various epidemiological methosds and their applications •! Understand the fundamental principles of pharmacoeconomics. •! Identify and determine relevant cost and consequences associated with pharmacy

products and services. •! Perform the key pharmacoeconomics analysis methods •! Understand the pharmacoeconomic decision analysis methods and its applications. •! Describe current pharmacoeconomic methods and issues. •! Understand the applications of pharmacoeconomics to various pharmacy settings.

THEORY 60 Hrs

UNIT I 12 Hrs

Introduction to Pharmacoepidemiology: Definition, Scope, Need, Aims & Applications; Outcome measurement: Outcome measures, Drug use measures: Monetary units, Number of prescriptions, units of drug dispensed, defined daily doses, prescribed daily doses, Diagnosis and Therapy surveys, Prevalence, Incidence rate, Monetary units, number of prescriptions, unit of drugs dispensed, defined daily doses and prescribed daily doses, medications adherence measurements.

Concept of risk: Measurement of risk, Attributable risk and relative risk, Time- risk relationship and odds ratio

UNIT II 12 Hrs Pharmacoepidemiological Methods: Qualitative models: Drug Utilization Review; Quantitative models: case reports, case series, Cross sectional studies, Cohort and case control studies, Calculation of Oddss ratio, Meta analysis models, Drug effects study in populations: Spontaneous reporting, Prescription event monitoring, Post marketing surveillance, Record linkage systems, Applications of pharmacoepidemiology

UNIT III 12 Hrs

Introduction to Pharmacoeconomics: Definition, history of pharmacoeconomics, Need of Pharmacoeconomic studies in Indian healthcare system. Cost categorization and resources for cost estimation: Direct costs. Indirect costs. Intangible costs. Outcomes and Measurements of Pharmacoeconomics: Types of outcomes: Clinical outcome, Economic outcomes, Humanistic outcomes; Quality Adjusted Life Years, Disability Adjusted Life Years Incremental Cost Effective Ratio, Average Cost Effective Ratio. Person Time, Willingness To Pay, Time Trade Off and Discounting. UNIT IV 12 Hrs Pharmacoeconomic evaluations: Definition, Steps involved, Applications, Advantages and disadvantages of the following Pharmacoeconomic models: Cost Minimization Analysis (CMA), Cost Benefit Analysis (CBA), Cost Effective Analysis (CEA), Cost Utility Analysis (CUA), Cost of Illness (COI), Cost Consequences Analysis (COA).

UNIT V 12 Hrs Definition, Steps involved, Applications, Advantages and disadvantages of the following: Health related quality of life (HRQOL): Definition, Need for measurement of HRQOL, Common HRQOL measures. Definition, Steps involved, Applications of the following: Decision Analysis and Decision tree, Sensitivity analysis, Markov Modeling, Software used in pharmacoeconomic analysis, Applications of Pharmacoeconomics

REFERENCES

1.! Brian L Strom, Stephen E Kimmel, Sean Hennessy. Pharmacoepidemiology. Wiley-

Blackwell

2.! R Brian Haynes, David L Sackett, Gordon H Guyatt, Peter Tugwell. Clinical

Epidemiology: How to Do Clinical Practice Research. Lippincott Williams &

Wilkins.

3.! Karen L Rascati. Essentials of Pharmacoeconomics. Lippincott Williams & Wilkins.

4.! Thomas E Getzen. Health Economics: Fundamentals and Flow of Funds. John Wiley

& Sons

5.! Andrew Briggs, Mark Sculpher, Karl Claxton. Decision Modelling for Health

Economic Evaluation. Oxford University Press.

6.! Michael F Drummond, Mark J Sculpher, Karl Claxton, Greg L Stoddart, George W

Torrance. Methods for the Economic Evaluation of Health Care Programmes. Oxford

University Press.

7.! George E Mackinnon. Understanding health outcomes and Pharmacoeconomics.

Johnes & Bartlett Publishers

8.! Dennis W Grauer. Pharmacoeconomics and outcomes: Applications for patient care.

American College of Clinical Pharmacy.

9.! Tom Walley, Alan Haycox, Angela Bolland. Pharmacoeconomics. Elsevier Health

Sciences.

10.!Dennis W Grauer. Pharmacoeconomics and outcomes: Case Studies. American College of Clinical Pharmacy

11.!Relevant review articles from recent medical and pharmaceutical literature

Pharmacy Practice Practical - II (MPP201P)

Pharmacy Practice practical component includes experiments covering important topics of the courses Principles of Quality Use of Medicines, Pharmacotherapeutics-II, Clinical Pharmacokinetics & Therapeutic Drug Monitoring and Pharmacoepidemiology and Pharmacoeconomics. List of Experiments (20)

1.! Causality assessment of adverse drug reactions (three) 2.! Detection and management of medication errors (two) 3.! Rational use of medicines in special population (two) 4.! Presentation of clinical cases of various disease conditions adopting Pharmaceutical

Care Plan Model (six) 5.! Calculation of Bioavailability and Bioequivalence from the given data (two) 6.! Interpretation of Therapeutic Drug Monitoring reports of a given patient (three) 7.! Calculation of various Pharmacoeconomic outcome analysis for the given data (two)

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